This post by Mary Dimmock appeared today on Occupy CFS. Mary raises some valuable points that have profound implications not just for people with ME, but for those with GWI, cancer, thyroid conditions, MS, and a host of other diseases. If ME is to be subsumed into a vague general category of "fatiguing illnesses" what's to prevent the IOM from "undefining" other diseases as well? (The IOM has already "undefined" GWI.) Will IBS, Interstitial Cystitis, and chronic Lyme follow suite? Will the remedies for these problems consist of a talk and a walk?

This scenario is not as far-fetched as it seems. Sloppy medicine breeds sloppy science (and vice versa). In this case, sloppy medicine could lead to a Pandora's Box of repercussions.________________________________________

Like the fundamental question: “What disease is HHS developing definitions for – ME or the diverse conditions that meet the overly broad “CFS” criteria?

I recently asked that question of both IOM’s Kate Meck and HHS’ Dr. Nancy Lee. From their answers, which I summarized below, the only possible conclusion is that the IOM study is intended to establish diagnostic criteria for the diverse conditions that meet the overly broad “CFS” criteria and that ME will be treated as a subgroup.

All of us, patients, advocates and experts alike, must reject this as completely unacceptable. We must call on HHS to acknowledge that ME is not part of the overly broad CFS. We must continue to call on HHS to adopt the Canadian Consensus Criteria.

We all know the problem. ME, the neurological disease characterized by post-exertional malaise, cognitive issues and immunological dysfunction has been buried inside of “CFS”, a diverse collection of medically unexplained fatiguing conditions. Numerous authors, especially Dr. Jason of DePaul, have reported extensively on the serious research and clinical problems caused by these overly broad CFS definitions, definitions that lump biologically unrelated conditions together. Dr. Bruce Carruthers summed it up simply, “There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome.”

Having rejected the Canadian Consensus Criteria as unacceptable, HHS is conducting three separate initiatives to develop its own criteria. But what does HHS intend to do about the “web of confusion” that has been created by “CFS”? What disease will these new criteria describe?

The ME/CFS IOM Statement of Work is ambiguous on this point as it uses the same jumbled, non-specific disease labels that have gotten us into this mess to begin with. The SOW states:"the Committee will consider the various existing definitions and recommend consensus clinical diagnostic criteria for this disorder [ME/CFS]. . .The Committee will also distinguish between disease subgroups . . .For the purposes of this document, ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness."I asked both Kate Meck at the IOM and Dr. Lee, the designated federal official for the CFS Advisory Committee (CFSAC) to clarify what “scope of disease” had been specified in the IOM contract. Has the IOM been contracted to develop clinical criteria specifically for ME? Or has IOM been contracted to develop clinical criteria for the range of unrelated fatiguing conditions that meet the “CFS” criteria? I asked Dr. Maier of NIH and Dr. Beth Collins-Sharp of AHRQ a similar question on the NIH Evidence Based Methodology Workshop process and am waiting on a promised response.Here’s a summary of the responses I received from Dr. Lee of HHS and Kate Meck of the IOM:

Both Dr. Lee and Ms. Meck said that the scope of disease to be covered by the new clinical criteria has not been specifically defined at this point and that this will need to be defined as the process goes forward.

Dr. Lee indicated that the panel itself would need to resolve this issue and that possible outcomes could be ME as a subgroup of the broader CFS, ME as part of a spectrum that includes these other conditions, or ME as a separately defined disease. Ms. Meck indicated that HHS would be asked to clarify what scope of disease was intended at the first meeting. I raised the concern with Ms. Meck that the scope of disease directly affects panel selection and evidence base selection but she felt that the panel and process would be able to adjust as needed.

In a follow-up email, Dr. Lee confirmed the above statements but also reiterated an earlier point she had made that the IOM task list specifies that the “committee will also distinguish between disease subgroups”. She also said that in order for the target audience – defined as the primary care physicians – to effectively use the resultant guidance, “it is important to start a bit broad and then have criteria which distinguishes between subgroups.”

These answers are profoundly disturbing.

First, the statement that the scope of disease has not yet been defined is frankly hard to believe. This is a million dollar contract and panel selection is due to be announced soon. How can such a critical issue as the scope of disease to be covered by the new criteria be undecided at this point? If it really is undecided, who will decide and how? What criteria have been used to select the panel? And will that panel still be the appropriate one once a decision is reached on what disease or diseases the new criteria will cover?

But the statements about subgroups and spectrum of illnesses are much more disturbing.

Yes, ME is a complex disease that needs to be broken down into legitimate subgroups in order to better understand the disease and the treatment options. Perhaps those subgroups are based on whether onset is sudden or not, the level of severity of the disease or the nature of the immune profile and viral load. But let’s be realistic. What is the likelihood that the panel selected for the IOM study is going to be able to identify proper subgroups of ME itself when our experts are still working through that? Or when the evidence base lacks the ME specific studies – studies done with proper ME definitions – that would be needed to substantiate ME subgroups?

At the same time, we have an agency with a long-term commitment to studying medically unexplained chronic fatigue as the single clinical entity, “CFS”. We have an agency that has taken the position that Oxford, Fukuda and the Canadian criteria all describe the same set of patients for whom one set of clinical guidance is appropriate. We have an agency that questions the scientific evidence surrounding even post-exertional malaise and its measurement while simultaneously rejecting the Canadian Consensus Criteria because it does “not account for scientific evidence developed since 2003.” We have the CDC’s Dr. Unger, rhetorically asking at the May 2013 CFSAC “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?” And we have the IOM adopting the same overly broad view of CFS as HHS in recent IOM publications on Gulf War Illness.

Now we have Dr. Lee stating that the target audience of the new criteria is the primary care physicians and that they need criteria that start broader and then distinguish between subgroups. What about the patients who desperately need criteria that accurately reflect their disease?

What are we to conclude from all this? HHS has not committed to criteria specific to ME. HHS is not talking about the proper subgroups of ME that we all envision. HHS intends the IOM study to define criteria for the broader set of CFS conditions, with ME characterized as a subgroup. Or worse, ME becomes a subgroup of the even broader chronic multisymptom illness (CMI).

Either way, this will be a disaster that will degrade ME research and worsen the abysmal clinical care and stigma that ME patients receive today. This is the nightmare scenario that we all fear.

If HHS truly wants to reverse the chaos and the grievous harm to patients caused by years of sloppy definitions, it will first and foremost declare that ME, the disease described by the Canadian Consensus Criteria, is not the same disease as the overly broad “CFS” and should not be considered as either a subgroup of CFS or part of a spectrum of CFS diseases.

And if HHS cares not only about primary care physicians but also about the ME patients that they treat, it will acknowledge the harm done to patients by its clinical guidelines as reported at a recent Mount Sinai conference. CDC will immediately highlight PEM as a hallmark symptom of ME, will provide “black box warnings” about the adverse effects of exercise on ME patients and will point clinicians to the Canadian Consensus Criteria and the IACFS/ME primer.

Beyond that, HHS needs to immediately require that the Canadian Consensus Criteria be used in every study funded by NIH, even if it is used in parallel with Fukuda as an interim step.

Patients, advocates and experts alike must demand and accept no less, especially in the context of the IOM study and the NIH Evidence Based Methodology process.

Jennie Spotila, ME/CFS Advocate, posted this piece on her blog, Occupy CFS, today. For those who have been wondering whatever happened to the request for an investigation into the intimidation of CFSAC members who sought to represent patient interests, the answer has finally come. And the answer is ... _________________________________Nothing to See Here

After more than four months, Assistant Secretary Dr. Howard Koh has finally responded to our request for an investigation into the allegations that Dr. Nancy Lee attempted to intimidate at least two voting members of the CFS Advisory Committee. His response boils down to something along the lines of, “OK people, move along, nothing to see here.” In fact, his letter is so dismissive of the allegations and so vague on what he’s done about it, that it barely qualifies as a response at all.Quick Review of The FactsAt the May 2013 CFSAC meeting, Eileen Holderman and Dr. Mary Ann Fletcher said that they had been intimidated by Dr. Nancy Lee and threatened with removal from the Committee for expressing their views. They said a third CFSAC member had also been intimidated.

On June 21st, the matter was referred to Assistant Secretary Koh. On August 22nd and September 20th, we wrote to Dr. Koh and requested an update on the investigation. We received no response or acknowledgement of our requests.

A Non-Responsive Response

In an letter to Mary Dimmock dated October 31st (but not received by her until November 7th), Dr. Koh finally responded. You can see the full letter here, but I’ll parse the salient points for you:"The concerns that have been expressed by the members will be taken into consideration as the Committee moves forward in working to accomplish its mission."This makes no sense at all. Eileen Holderman and Dr. Fletcher did not express “concerns.” A concern is something along the lines of I’m-concerned-that-we-don’t-get-meeting-materials-in-advance. That’s a concern that can be “taken into consideration.” Holderman and Fletcher made allegations of improper conduct by the Designated Federal Officer of the Committee. That’s more than a concern. But Koh doesn’t even acknowledge the nature of the allegations. Nor does he describe what he did to investigate them."However, it is important to understand that the Designated Federal Officer for CFSAC, Dr. Nancy C. Lee, has authority to engage in private conversations with individual members of CFSAC."I am not aware of anyone disputing that Dr. Lee can talk to individual members of CFSAC. The allegations were not about the propriety of Dr. Lee talking to CFSAC members. The allegations were about what she said. This is what we asked the General Counsel to investigate: Did Dr. Lee tell one or more members of CFSAC that he or she could be removed from the Committee for expressing a point of view? That is the question that must be answered."These discussions may be confidential in nature . . ."Um, okay. As far as I am aware, CFSAC doesn’t deal in matters of national security. They don’t receive confidential corporate documents the way members of FDA advisory committees do. I have no idea what’s so hush hush about it. But even if I accept the proposition that certain discussions are confidential, I hear something a bit ominous in this comment from Dr. Koh. By telling us that those discussions might be confidential, is he saying that Holderman and Fletcher have done something wrong in making their allegations public? Is he actually claiming that they are not permitted to disclose conversations that, at least in their opinion, represent improper behavior by a federal official? Seriously? Is he suggesting that there will be a backlash against any member who speaks out about that kind of behavior? Really?

". . . and also may involve providing information about the rules and regulations of the Federal Advisory Committee Act as they relate to managing CFSAC and the roles and responsibilities of the Committee members."

Permit me to decode this for you. What this sentence tells me is that Dr. Koh did look into the allegations, although he is completely silent on who he spoke with or what that involved. The sentence also tells me that his conclusion is that Dr. Lee provided information to Holderman and Fletcher (and perhaps the third member too) about the rules and regulations of FACA as it applies to them, and that is the only thing Dr. Lee did.

This simply does not add up. FACA does not state that advisory committee members can be removed for expressing their points of view. After all, the advisory committee exists for members to do precisely that. Furthermore, FACA requires that advisory committees have a balance of membership and views, so removing a member for expressing a different point of view would unbalance the committee and potentially violate FACA.

Either Fletcher and Holderman are not telling the truth about what Dr. Lee said to them, or Dr. Lee is not telling the truth about what she said to them, or there has been some kind of epic misunderstanding that Koh has failed to identify. And since Koh’s letter gives us no information about whether an investigation was conducted, who was interviewed, and what the findings were, we have no ability to unravel this mess."All engaged in this activity should conduct themselves in a manner that is conducive to respectful and candid discussions."I think this sentence is code for: one or more people are not conducting themselves appropriately and they should knock it off. Of course, the letter does not specify who needs to knock it off. But read between the lines. He has already said that Lee behaved appropriately. So the only people left to knock it off would be the CFSAC members who complained.

Completely Unacceptable

This non-responsive response is unacceptable for so many reasons, it’s hard to know where to begin. We started with seeking advice from multiple sources, including legal, political and advocacy sources. After consultation with a variety of sources, Mary Dimmock has sent a second letter to the General Counsel of HHS. You can read the full letter here, but these are the main points:

Dr. Koh failed to adequately investigate and resolve the allegations.

Dr. Koh’s letter contains no evidence or assurance that these allegations are unfounded.

The failure to resolve the allegations is not at all conducive to respectful and candid discussions.

Public trust and confidence in the work of the Committee has been undermined and all but destroyed.

The public cannot trust that Committee members are free to provide honest advice to the Secretary.

The letter then renews our request, that the General Counsel and not Dr. Koh:"investigate these allegations immediately, and establish whether any voting member of the CFSAC has been intimidated or threatened for expressing their opinions. At a minimum, your response should detail what steps were taken to investigate, your findings on the facts that support or refute the allegations, and what specific corrective action has been taken."Will it work? I’m not certain. On the one hand, the General Counsel handed us off to Koh before. On the other, Koh’s response is so vague and the issue of public trust so significant, that the General Counsel certainly should step in and do the right thing. I think it’s vitally important to get matters like this on the public record. We are accumulating more and more evidence of a systematic pattern of ignoring our concerns, downplaying the seriousness of the situation, and flat out subversion of good government practices. There are plenty of other people who are interested in this sort of thing, even if the General Counsel isn’t.

It never ceases to amaze me. Do they think we’re stupid? Do they think that hand waving and “These aren’t the droids you’re looking for” Jedi mind tricks actually work? Or are they counting on the media or Congress or the Office of Inspector General* being completely uninterested in what’s going on? We’ll see.

Note: Remember, there is a difference between the Office of the General Counsel (which “supports the development and implementation of the Department’s programs by providing the highest quality legal services”) and the Office of Inspector General (which is “dedicated to combating fraud, waste and abuse and to improving the efficiency of HHS programs.”)

This critical essay appeared on ME Action recently. Simon Wessely is not the only proponent of the "it's all in their heads" theory of ME, but he is the most influential. In spite of overwhelming evidence to the contrary, Wessely, a devotee of armchair reasoning, has clung to the quaint Freudian notion that illnesses are created by the mind (hysteria, aka conversion disorder). This type of voodoo medicine, as Margaret Williams has so aptly pointed out, has absolutely nothing to do with science - or medicine.__________________________________________________Professor Sir Simon Wessely – Right or Wrong?

By Margaret Williams ~ 28th October 2013

When a professional person – especially a doctor – has repeatedly been shown to be wrong in their professional judgment and, as a direct consequence, people have been harmed, that doctor should surely be held personally responsible and accountable: in such circumstances legitimate criticism should not be dismissed as an ad hominem (personal) attack.

Following the award of the inaugural John Maddox Prize to psychiatrist Professor Sir Simon Wessely for his alleged “courage” in “standing up for science” and for promoting “sound science” about ME/CFS in the face of “hostility” in doing so, a letter published on 13th January 2013 by the Countess of Mar, Professor Malcolm Hooper and Dr William Weir in The Independent on Sunday was explicit that criticism of Wessely’s hypothesis about ME/CFS is scientifically legitimate:

“Scientific understanding always depends upon sound evidence….For scientific understanding to prevail, the extensive biomedical evidence-base of ME/CFS must now be recognised by all researchers in the field. The idea that ME/CFS is due to a dysfunctional psyche is a hypothesis without an evidence-base. The Maddox Prize was therefore awarded to the defender of an hypothesis with no evidence-base rather than to someone who was upholding true scientific inquiry. Personal attacks against Professor Sir Simon Wessely do not advance the cause, but it is scientifically legitimate to direct criticism at the hypothesis both he and Professor White (chief Principal Investigator of the MRC’s PACE trial on ME/CFS) continue to espouse”.

It has been shown time and again that Professor Sir Simon’s published assertions about disorders such as ME/CFS, fibromyalgia, Gulf War Syndrome, the Camelford drinking water poisoning, and interstitial cystitis are simply wrong. Merely stating so is likely to result in yet more claims by him of “harassment” and “attack” upon him but, in the words of Professor Martin Bland, one of the UK’s leading medical statisticians, it is important that false information should not remain on the record to be quoted uncritically by others: “Potentially incorrect conclusions, based on faulty analysis, should not be allowed to remain in the literature to be cited uncritically by others” (Fatigue and psychological distress. BMJ: 19th February 2000:320:515-516). Wessely’s “incorrect conclusions”, however, remain in the literature to be cited uncritically by others and therefore may result in iatrogenic harm.ME/CFS

For over 25 years Wessely’s dismissal and rejection of the biomedical evidence on ME has continued unabated, even though there is substantial evidence of on-going inflammation throughout the body; systems prominently affected are the central and autonomic nervous systems, the immune system and the cardiovascular, endocrine, gastro-intestinal and musculoskeletal systems.

Unscientifically, he conflates ME, CFS, PVFS and chronic “fatigue” into what he refers to as “CFS”. This has become a waste-basket label, with 40% of those afforded it subsequently being shown to have other diagnoses (J R Coll Physicians Edinb, 2010:40(4):304-307).

Despite the extensive biomedical evidence that shows him to be wrong, Wessely is certain that he is right: he believes that ME/CFS is a behavioural disorder that should be managed with “cognitive restructuring”specifically designed to convince sufferers that they are not physically sick.

Indeed In October 2003, in a frenzied attack on people with ME and on those scientists and clinicians who regard it as an organic disorder, Wessely raged that those who disagree with him and believe ME to be an organic disorder (to whom he referred as “the radicals”) are “crazy” and that they are “engaged in fantasies, lies and gross distortions”. He wrote that the “radicals” are left “fighting yesterday’s battles” (seemingly because he believes he has established that ME does not exist except as a false illness belief), that they need a “reality check” and that “their behaviour is outrageous” (private communication; available to Medical Defence Union lawyers on legitimate request).

Ten years later, his views have not progressed in line with the advancement of medical science: at a medical meeting in March 2013 held in Bristol, Wessely informed attendees that ME has been caused almost entirely by what he called the “shockingly” negative way in which some ME charities, in particular the ME Association, portray it as a viral illness, saying that this has harmed patients as it encourages them to focus too much on symptoms and to be fearful of activity, resulting in a vicious cycle of deconditioning. Making no distinction between chronic “fatigue” and ME/CFS, doctors were assured by Wessely that all patients with CFS would benefit from the same management regime, namely behavioural therapy and exercise (Research in Chronic Fatigue Syndrome – ups and downs; Bristol Medico-Chirurgical Society; 13th March 2013: approved as a Continuing Medical Education module).

The continued propagation of such erroneous beliefs is a matter of significant concern because of their potential harm to very sick people, so it may be appropriate to re-consider the evidence that proves Professor Sir Simon to be wrong about four other issues as well: fibromyalgia, Gulf War Syndrome, the Camelford poisoning tragedy, and interstitial cystitis.

Fibromyalgia

As with ME/CFS, Simon Wessely believes that fibromyalgia (FM) is a functional somatic disorder (Lancet 1999:354:936-939), despite the fact that FM is formally classified in the World Heath Organisation’s ICD-10 at M79 as a soft tissue disorder. FM was officially recognised as a syndrome on 1st January 1993 by the WHO as a result of the Copenhagen Declaration (Consensus Document on Fibromyalgia: The Copenhagen Declaration 1992). It is a systemic disorder and affects not only the muscles – including the heart – but also the gut and immune system, and these are all recognised features of FM.

Israeli researchers have pointed out that FM is believed to be the result of a central nervous system malfunction and emphasised that: “many of the differential diagnoses can be excluded by means of an extensive clinical examination and patient history” (Autoimmun Rev 2012 Jun:11(8)585-588), but Wessely advises against extensive clinical examination, claiming that it supports patients’ false beliefs that they are physically ill.

Whilst Wessely has not changed his position that fibromyalgia is but one part of a unified functional somatic syndrome, medical science has shown that in fibromyalgia, there is objective evidence of:

aberrant expression of immune mediators (cytokines), with impairment of cell-mediated immunity, providing evidence that FM is an immunological disorder which occurs independently of any subjective features (BMC Clinical Pathology, 17th December 2012:12:25)

biochemical differences (changes in tryptophan catabolism pathway) that are quite distinctive from those found in osteoarthritis or rheumatoid arthritis (Analyst Issue 16, 2013)

a mismanaged blood flow and low levels of inflammation, with a unique peripheral neurovascular pathology consisting of excessive peptidergic sensory innervation of cutaneous arteriole-venule shunts (AVS) in the skin of FM patients confirmed by multimolecular immunocytochemistry, with blood flow dysregulation as a result of excessive innervation to AVS contributing to widespread deep pain and fatigue (Pain Medicine: June 2013:14:6:895-915)

In addition to these demonstrable abnormalities, there is no objective link to psychiatric disease in fibromyalgia (BMC Clinical Pathology 2012:12:25) and furthermore, there is evidence that the use of antidepressants in long-term treatment of fibromyalgia resulted in a worse impact of the disease on patients’ daily lives, with worsened quality of life and deterioration in long-term management (Clin Pract Epidemiol Ment Health 2013:9:120-124).

Evidentially, Wessely’s aberrant belief that fibromyalgia is but one component of a single functional somatic syndrome has been vitiated and he has been proved wrong.

Gulf War Syndrome

Simon Wessely was knighted in the 2013 New Year Honours List for his work on “military health”; he is civilian psychiatric advisor to the UK Ministry of Defence where, despite his having no case definition of Gulf War Syndrome (GWS), he has consistently denied its existence, ascribing it to “stress of combat” and to a “belief” of exposure to a chemical attack (Lancet: 16th January 1999:353:169-178). Despite having been funded to the tune of $1 million by the US Pentagon, Wessely and his co-psychiatrist Professor Anthony David (both described as “specialists in unexplained syndromes”) definitively concluded that exposure to chemical weapons was not the cause of Gulf War veterans’ health problems (US cash for study of Gulf victims. Jeremy Laurence. Independent: 4” June 1997).

Sixteen years later, Wessely’s view apparently still pertains throughout the UK Ministry of Defence.

In contrast, US scientists have shown that Gulf War veterans’ chronic ill-health is indeed linked to toxic causes and it is clear that Gulf War Illness/Syndrome cannot be associated with stress or any psychiatric disorder: it is associated with poisoning by the cholinesterase inhibitors sarin and organophosphates (these being known neurotoxins which give rise to multi-system illness) combined with the effect of pyridostigmine bromide which acts synergistically with them (US Congressionally Mandated Report of the Research Advisory Committee on Gulf War Illness – Findings and Recommendations; 13th June 2012).

Further, a large study led by Robert Haley, Professor of Internal Medicine and Chief, Division of Epidemiology, University of Texas Southwestern Medical Centre, confirmed cholinergic dysfunction in affected Gulf War veterans (Archives of Neurology, 26 November 2012: 1-10). The authors concluded: “Autonomic symptoms are associated with objective, predominantly cholinergic autonomic deficits in the population of Gulf War veterans”, with affected veterans displaying orthostatic intolerance, secretomotor dysfunction, upper gastrointestinal dysmotility, sleep dysfunction, urinary dysfunction and autonomic diarrhoea.

As Haley pointed out: “It takes this out of the realm of psychological illness into the realm of a brain illness” (Gulf War Illness linked to Cholinergic Abnormalities. Pauline Anderson: Medscape 26 November 2012).

The statistics show that almost one third of UK troops who were deployed or were prepared for deployment to the Gulf (which equates to between 13,250 and 15,900 previously fit and healthy personnnel) remain chronically sick. Death statistics from GWS are impossible to obtain because once the sick Gulf War veterans have left the armed forces, they are passed to the care of the NHS and no extant medical records for service personnel are made available to the NHS – they have been either destroyed or retained by the MoD. (It is notable that in 1997, Wessely forecast that Gulf War veterans’ “contemporary records…may be difficult to obtain”: BMJ 1997:314:239-240).

Thus convincing evidence exists that proves Wessely is wrong in asserting that Gulf War Syndrome does not exist and that veterans’ ill-health is merely the result of their own misperceptions.

The Camelford water poisoning tragedyWessely not only denies the existence of ME and of Gulf War Syndrome: he has denied that residents of Camelford were poisoned by aluminium sulphate. In July 1988, 20 tonnes of aluminium sulphate were accidentally pumped into the drinking water supplies of the small town of Camelford in Cornwall. It was reported that in the Camelford catastrophe, seven people died; 25,000 suffered serious health effects, and 40,000 animals were affected. (Dr Douglas Cross. The Ecologist:1990:20:6:228-233). Five years later, an article by Bernard Dixon entitled “Still waters” was published in the BMJ (5th August 1995: 311:395); it informed readers that: “mass hysteria was largely responsible for the furore”. Dixon’s article was based on a 1995 “re-assessment” of the Camelford incident by psychiatrists Anthony David and Simon Wessely which was published in the Journal of Psychosomatic Research (1995:39:1-9). Dixon noted that David and Wessely had found that anxiety was the cause of the symptoms and that there was no evidence of long-term adverse effects on health as a consequence of the drinking water contamination.

However, David and Wessely’s confident assertion that mass hysteria and/or anxiety were responsible for the supposed suffering of those in the Camelford area at the time of the incident has been shown to be wrong. Paul Altman et al showed that Camelford residents who were exposed to aluminium sulphate-contaminated drinking water suffered considerable damage to cerebral function which was not related to anxiety, and that there was objective evidence of organic brain damage compatible with the known effects of exposure to aluminium (BMJ 1999:319:807-811). Altman et al reported that previous psychological studies on victims of the Camelford incident which concluded that: “the perception of normal and benign somatic symptoms (physical and mental) by both subjects and health professionals was heightened and subsequently attributed to an external cause, such as poisoning” were demonstrably erroneous.

Twenty-five years after the catastrophe, the UK Government apologised to those affected “unreservedly” for the way in which the incident was dealt with at the time (BBC News Cornwall, 19th September 2013).

It remains to be seen if Simon Wessely will also apologise unreservedly to those whom he denigrated by dismissing their symptoms as anxiety. Quite how hair, skin and nails turning blue, and bone biopsies showing stainable aluminium over six months later could possibly be due to anxiety has not been explained by Wessely.

Again, Wessely has been proved wrong in ascribing serious and chronic physical ill-health to aberrant perception not only by those afflicted but also by those medical professionals who supported them.

Interstitial cystitis

In 2009 the BMJ carried a well-structured Clinical Review of interstitial cystitis/bladder pain syndrome (Serge Marinkovic et al: BMJ 2009:339:337-342) in which the authors provided a compelling case – based on evidence of bladder epithelial damage and related blood vessel transitions activating mast cells and generating an autoimmune response – of likely autoimmune causation.At once Wessely sprang into action, rejecting outright any autoimmune or allergic component and noting the association with chronic fatigue syndrome, asserting that there was “good evidence” for the role of psychological factors in both the aetiology or maintenance of both conditions and stating that physical pathology cannot fully account for the symptoms (http://www.bmj.com/cgi/eletters/339/jul31_2/b2707#218935).

In 2012 it was established that patients with interstitial cystitis/painful bladder syndrome demonstrated measurable systemic dysfunction, with central and autonomic nervous system disorders and high rates of syncope as well as gastrointestinal dysfunction (Chelimsky G et al. Front Neurosci 2012:6:114: Epub 10 August 2012).In October 2013, researchers again proved Wessely wrong (Jiang Y-H et al; Increased Pro-Inflammatory Cytokines, C-Reactive Protein and Nerve Growth Factor Expression in Serum of Patients with Interstitial Cystitis/Bladder Pain Syndrome: PLoS ONE 8(10): e76779. doi:10.1371/journal.pone.0076779).They demonstrated increased pro-inflammatory cytokine/chemokine (IL-1ß, IL-6, TNF-α and IL-8) expression in the sera of IC/BPS patients, implying not only mast cell activation but also that other inflammatory mediators play important roles in the pathogenesis, and supporting the fact that interstitial cystitis/bladder pain syndrome is now considered a chronic inflammatory disease.Conclusion

Wessely’s attempts to re-classify as a single somatoform disorder various disparate physical syndromes have failed. As the Countess of Mar et al so concisely commented, the Maddox Prize was “awarded to the defender of a hypothesis with no evidence-base rather than to someone who was upholding true scientific inquiry”. There are many who maintain that, contrary to “standing up for science”, the award to Wessely militates against medical science and actively devalues it.

Every once in a while, I run across an article that is like a light bulb going on in my head. This article on Lyme disease was one of those "Aha!" moments I truly cherish. The CDC's announcement last April that there were 10 times more people with Lyme disease than they had previously reported raised some eyebrows. How had the CDC missed counting 270,000 new cases a year?

The answer is they didn't. Epidemiologists have not come up with any new methods for counting people with diseases. The numbers only increased once there was a way to make money from the illness - a lotof money.Do I sound like a cynic? I'm not. I simply have a long memory.

In the early 1990s, the CDC estimated that there were 20,000 individuals in the U.S. with CFS, making it a rare disease. This was during a period when the CDC was downplaying the importance of outbreaks that had been occurring all over the country (and world, as it turned out) for political reasons. (AIDS was causing a panic.) Ten years later, this number had risen to nearly a million. Did 980,000 people suddenly contract CFS during that period of time? If so, that would have placed its rise in prevalence on the order of the plague.

The problem with the CDC's prevalence and incidence reports concerning CFS is that the numbers are not driven by an objective desire to understand how many people actually have, or are contracting, the illness. The numbers are the product of whatever directives the CDC may be following for the sake of whoever stands to profit or lose from them. In the case of Lyme, the numbers were low until a prospective vaccine was developed that the maker is proposing be given to every person in the United States. (I can't even begin to do the math on those kinds of profits.)

In the case of CFS, the numbers were low while the CDC was denying its existence, then rose once the illness was equated with a psychiatric disorder that could be treated with antidepressants, and which did not warrant long-term disability payments. In sum, all those millions of people who are "tired" for long periods of time, and whose doctors can't come up with a diagnosis for an "organic" illness in the 10 minutes they spend taking a history - and with the three tests they order - could now be pushed off on the next passing ice floe with a bottle of Elavil, saving billions of dollars for the insurance industry.

Do I sound bitter? I'm not. I'm outraged.____________________________________________________________Lyme Disease Community Blows the Whistle on Corruption Within the CDC

The Centers for Disease Control and Prevention (CDC) recently announced that rather than 30,000 new cases of Lyme disease each year in the United States, there are likely 300,000. What the CDC failed to explain is why it's taken them so long to acknowledge that Lyme disease has reached epidemic proportions.

The Lyme disease community has been battling for years to get the CDC to admit that Lyme disease is a mass public health crisis. Meanwhile, the CDC itself has been informally saying since 2004 that Lyme disease is probably 6 to 12 times more prevalent than the reported cases. Why then have they suddenly decided to formally acknowledge these higher rates?

On a recent "Your Own Health and Fitness" show about Lyme disease on KPFA radio in Berkeley, Calif., host Layna Berman observed that the announcement of increased rates coincides with a financial interest in releasing the new Baxter Lyme vaccine:

"With this announcement of the increased number of cases, we might imagine that an economic opportunity has presented itself. . . .The treatment favored by doctors who treat chronic Lyme . . . is long courses of antibiotics . . . But these treatments aren't money makers. So what inspired the CDC after so many decades of ignoring and denying chronic Lyme to release these new statistics? The promise of a new vaccine."

David Egan, Irish ME advocate and signatory of the Advocates' letter to HHS Secretary Sebelius, has been conducting a correspondence with the IOM concerning conflict of interest and bias in their evaluation of ME/CFS.

As written responses from the IOM, or any government agency are rare, I am printing it below. Not surprisingly, it consists entirely of a statement of expertise, and a challenge to offer our input. (It should be pointed out that the IOM is under no legal obligation to accept any of our input.)

Scroll down to read David Egan's reply, in which he challenges the IOM, not based on its statement of purpose, but on no less than five of its own reports, in which IOM's"'independent' committees of 'experts' recommended totally ineffective, inaccurate and harmful diagnostics and treatments for ME/CFS, specifically GWI soldiers with ME/CFS. They showed clear psychiatric bias and omitted important and vital biological scientific research and medical findings."If this were a trial, a recusal would be in order.

(You can read all of David Egan's letters to the IOM HERE.)*****************************November 18 2013 Dear David,

I appreciate you taking the time to express your concerns. The IOM study staff are committed to supporting this committee to develop evidence-based recommendations on diagnostic criteria for ME/CFS. We recognize the historical frustrations of the physician and patient communities in getting ME/CFS to be appropriately acknowledged and understood, and we want the committee’s work to make progress on these efforts, not hold them back. Let me respond to some of your concerns . . . First, the Institute of Medicine does not, as an organization, hold positions on the topics that are addressed by committees or other activities. Previous reports do not constitute a conflict of interest for the organization because IOM reports are authored by independent committees of experts. The IOM’s role is to assemble a committee with appropriate knowledge, with minimized and balanced intellectual biases, and without conflicts of interest. The Committee on Diagnostic Criteria for ME/CFS will be screened for intellectual biases and conflicts of interest.

You (and the rest of the public) will have the opportunity to formally comment on the provisional committee slate if you feel that the committee composition is unbalanced with regard to intellectual biases. I understand your concerns about the accuracy of the discussion of ME/CFS in the reports listed below. ME/CFS was not the focus of any of those reports, but it is the ONLY topic to be addressed by the Committee on Diagnostic Criteria for ME/CFS. This committee has been specifically tasked to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients. We will be conducting an extensive literature search to identify published materials for the committee to review and we will hold at least one public meeting to hear directly from the physician and patient communities. You (and the rest of the public) have the opportunity to send or recommend specific articles for the committee to review. The IOM staff will work closely with the committee to ensure that the report accurately reflects the evidence base, including biological/medical research. I hope that I have addressed some of your concerns.If you would like to be notified when the provisional committee slate is posted, please sign up for the project listserv. If you would like to send materials for the committee to review, you can send them to mecfs@nas.edu. Please note that all written materials provided to the committee will be placed in a Public Access File. If you have additional questions about IOM processes, you can contact Molly Galvin (cced here). Best,Kate Meck

Thanks for your assistance in this matter. You state, "The IOM’s role is to assemble a committee with appropriate knowledge, with minimized and balanced intellectual biases, and without conflicts of interest."

Yet in the 5 GWI reports your "independent" committees of "experts" recommended totally ineffective, inaccurate and harmful diagnostics and treatments for ME/CFS, specifically GWI soldiers with ME/CFS. They showed clear psychiatric bias and omitted important and vital biological scientific research and medical findings.

That's 5 reports by "independent" committees of "experts". Neither independence or expertise were shown by these individuals. This was a key failing of the IOM.

The credibility and reputation of the IOM has been affected by this lack of scientific and medical thoroughness. How could the IOM make the same mistake 5 times, and elect the same type of "independent" committees of "experts" with the same mistakes and omissions?

The IOM had ample opportunity to amend these 5 reports in line with scientific and medical accuracy and the protection of the public interest, but did not do so. The IOM owns the process which created these reports, selected the committees and owns the reports themselves, so it is not independent of the reports.

We are not holding the IOM back, it's far better to get the outstanding matters resolved than engage in another rushed job at IOM and have another meaningless and ineffective psychiatric based definition and more years and decades of suffering and premature deaths for ME/CFS patients in the USA and elsewhere. We are dealing with life and death issues here, as exemplified here at this link.IOM is holding itself back by failing to admit to its past errors, mistakes and omissions and breaches of its own guidelines. The IOM could decide to step aside until these matters are fully resolved and recommend the current best international practises in diagnostics for ME/CFS; these being Myalgic Encephalomyelitis: International Consensus Criteria, 2011. (This supercedes 'Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols (2003)' listed below.) ME Primer for Healthcare Professionals: based on Myalgic Encephalomyelitis: International Consensus Criteria, 2012 Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols, 2003 For Medical Doctors - Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Diagnostic and Treatment Protocols, 2003.

The word "propaganda" has gotten a bad rap. In our century, it has come to mean unreliable information that is used to manipulate public opinion. (Originally, propaganda referred to the Catholic Church's efforts at "propagating" the faith.)

To a certain degree, the negative connotations are deserved. Those who wish to manipulate public opinion without going through the effort of supporting and legitimizing an argument often take short cuts. References are cherry-picked, poor rhetorical strategies are used, such as ad hominem attacks, and, in the worst cases, facts may be invented, data twisted, and outright lies presented as truth.The post that appeared yesterday on the CAA website, "CFSAC Responds to Questions Concerning the Contract with the IOM" is not an example of the most disreputable form of propaganda - outright lies designed to inflame the public - but it does fall into the category of manipulation.

Information or manipulation?

The practice of answering FAQs - frequently asked questions - is one which provides answers to questions of general concern. FAQs enable readers to identify common problems, and quickly find concise answers.

People in the ME/CFS community certainly have questions about the IOM contract. I know I do. In fact, if someone were to ask me, right now, "What questions do you have?" I would be able to rattle them off in a heartbeat. How will this contract affect me? Will it have an impact on disability claims, medical care, research? Will the IOM "psychologize" the illness, making it even more of a stigma than it is now? Will we end up with "chronic multisymptom illness" as a new name, with a corresponding definition that is even more vague than the current one?

The questions I would not ask are the ones that appeared in the FAQs. Some of these questions were interesting. But it was very clear from their answers - the bulk of which came directly from the IOM website - that the purpose of the questions was not to address the real concerns of the ME/CFS community, but to provide a vehicle for "canned" information, supposedly from a source that is perceived as representing patient interests (CFSAC).

Stakeholders

Are the CAA FAQs propaganda? In the strictest sense, they are. The purpose of these FAQs is not to enlighten, but to persuade, which casts their intent into doubt. If we are not asking these questions, who is? And, who is providing the answers? And, in a more general sense, why is this person, or organization, trying to influence us? How do they benefit?

In this case, the phrasing of these FAQs answers the first two questions.

Whoever composed the questions - and their answers - is not knowledgeable about contract law (contracts, as any lawyer can tell you, can always be canceled), or interested in taking the time to formulate lucid answers (many of which were copied verbatim from the IOM website), or verbally adept (funds are not "repurposed" - a term Suzanne Vernon uses to excess - they are redirected).In addition, the person who wrote these FAQs prefers to remain anonymous (the general form "we" disguises authorship) and, like the email sent by the CAA asking the signatories of the experts' letter to HHS to revoke their signatures, works "behind the scenes."

As for who benefits from the contract and how - the CAA will benefit from its association with the IOM by renewing its ties to government agencies (in recent years their funding from government grants has shrunk), insurance companies will benefit by not having to pay for expensive treatments once CFS is officially defined as a psychological disorder, and HHS will benefit by making sure the status quo is not challenged.

A short quiz

I have copied the questions - but not the answers - below. Chalk up a point for every question that you don't actually care about or don't understand. Add two points for every question that appears to have a purpose other than addressing a real concern of the ME/CFS community. Add three points if the question is leading. (Hint: There are at least two.) And, if you care the read the answers, add ten points for every answer that does not satisfy you, or you can't understand, or you suspect isn't quite accurate. The more points you score, the more likely it is that these FAQs were intended to address "concerns" of the proponents of the IOM contract, rather than those of our community. Here are the questions. The answers are HERE.

Who is the target audience for the Institute of Medicine (IOM) study?

Why did the Department of Health and Human Services (HHS) not follow the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommendation to host a workshop in consultation with CFSAC and ME/CFS experts, but instead contracted [sic] with the IOM to do a study?

Can HHS, and all associated agencies, endorse the 2003 Canadian Consensus Criteria based on the recommendation of ME/CFS experts, patients and the International Association of CFS/ME? If not, why not?

What is the standard process that the IOM uses to develop its recommendations?

What criteria does IOM use for selection of committee members?

Does the HHS contract with the IOM specifically require the IOM to use ME/CFS experts as committee members?

Does the contract require the IOM to include a patient as a committee member?

How can patients, family members and other advocates provide input into the IOM study process?

What is the Statement of Task [sic] in this contract with the IOM?

Will the IOM study address treatment for ME/CFS?

What is the total cost of the IOM contract?

If the IOM contract is cancelled [sic], will the contract funds go to ME/CFS research?

What is the difference between the IOM committee charge and the NIH Evidence-based Methodology Workshop for ME/CFS?

This article (see below) appeared a few days ago on the website Lawyers and Settlements. For those of us who are battling private insurance companies for disability benefits, Christine's case is enlightening.

Why was Christine refused long-term disability by her private insurer? According to the article

"insurance representatives don’t believe [people with CFS] are disabled. Instead, they are often considered “lazy” and “hypochondriacs,” and capable of work."To clarify: Insurance claims are not denied based on the private beliefs of insurance representatives. Christine's claim was denied because Cigna has a policy regarding "chronic fatigue syndrome" based on information supplied to them by doctors employed by the company as medical consultants. These doctors, in turn, base their opinions on documents they have read - such as the PACE trials, and other pseudoscientific studies - that are, in large part, influenced by insurance companies which do not want to pay for long-term disability.It's a vicious, venal circle.Once the IOM officially redefines "chronic fatigue syndrome" as a "functional" illness that can be treated with exercise, therapy and antidepressants, it is doubtful that any insurance company will pay long-term disability benefits for ME/CFS.___________________________________________________

Detroit, MI: Despite the fact that disability insurance is supposed to protect policyholders in the event they become disabled prior to retirement, some insurance companies still practice bad faith insurance by wrongly denying disability claims for chronic fatigue syndrome. Why was Christine denied benefits by Cigna, her Insurer, yet immediately recognized as disabled by Social Security?Read the rest of this article HERE.

The accusation of bias is neither far-fetched nor hypothetical. IOM has already stated that CFS is a functional disorder (i.e. psychological), and that treatments should consist of therapy, exercise and antidepressants. The IOM did not cite any credible studies to back their conclusion. Because the IOM has already published its opinion regarding CFS, and because that opinion has not been supported by scientific evidence, IOM is therefore not qualified to devise a definition for ME/CFS.___________________________________________________

Re: Conflict of Interest of the Institute of Medicine With Respect to Its Contract with DHHS Regarding ME/CFS

Dear Mr. Levinson,

I respectfully request your review of a serious conflict of interest in a recently concluded $1 million contract (“IOM Contract”) between the Department of Health and Human Services (“DHHS”) and the Institute of Medicine (“IOM”) to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”).

I am a patient who has suffered from this disease since 2006.

The IOM Contract was announced on September 23, 2013. It was entered into on a rushed and alarmingly secretive basis despite a deafening outcry by the patient community against it. The IOM Contract has so far not been terminated despite the agreement of virtually all U.S. and a fair number of international ME/CFS experts to adopt the 2003 Canadian Consensus Criteria (“CCC”) as the case definition (or diagnostic criteria) for ME/CFS and the opposition to the IOM Contract by these experts (both also on September 23, 2013) and by over 170 representatives of the patient advocacy community (on November 9, 2013). The experts’ consensus negates the need for the IOM Contract and the waste of $1 million in taxpayer money. Nevertheless, Secretary Sebelius has, to this date, not had the courtesy to reply to the experts and advocates. To the contrary, the IOM Contract is being pushed through at an unprecedented speed.

48 C.F.R. section 9.505 sets up the underlying principles in avoiding or mitigating organizational conflicts of interests, including “preventing the existence of conflicting roles that might bias a contractor’s judgment.”

In this case, the IOM has clearly and unabashedly demonstrated its bias relating to the ME/CFS diagnostic criteria. It did so just earlier this year in its report on Chronic Multisymptom Illness (Gulf War and Health: Treatment for Chronic Multisymptom Illness (“CMI Report”)).

Just to give a few examples, the CMI Report unconditionally accepts antidepressants (page 119) as well as cognitive-behavioral therapy and graded-exercise therapy (page 99) as recommended treatments for ME/CFS even though these “treatments” are viewed by most if not all credible experts as not just unhelpful, but potentially quite harmful for most ME/CFS patients. Exercise is said, in the CMI Report, to have been shown to improve ME/CFS symptoms (page 99) when the potential harm of exercise to ME/CFS patients has been clearly established. At best, if you take into account “research” that has not followed the scientific method, this form of “treatment” is controversial, with most experts agreeing that it is harmful. But it is definitely not a “treatment” recommended by credible ME/CFS experts. This ties directly into the diagnostic criteria for ME/CFS because exercise triggers a post-exertional worsening of symptoms—the hallmark feature of ME/CFS—which is why it is even part of the current woefully inadequate 1994 CDC Fukuda case definition.

The CMI Report also opines that there are no biomarkers for ME/CFS (page 203) when the IOM-contract study is to determine whether there are biomarkers and what they are. Furthermore, the CMI Report opines that ME/CFS is not “an organic disease” (page 22).Throughout the CMI Report, the IOM references ME/CFS and, in particular, its case definition, symptoms and treatment modalities. These are all used as critical building blocks in reaching the IOM’s conclusion regarding treatment of Chronic Multisymptom Illness. The case definition and symptoms and possibly treatments of ME/CFS are at the heart of the IOM Contract. The conflict here is obvious. The IOM is wedded to the CMI Report’s conclusions from just earlier this year that is based in part on its assumptions and conclusions about ME/CFS. That represents a substantial bias in favor of not contradicting its prior assumptions and findings and prejudices the IOM against adopting findings that are inconsistent with the CMI Report.

When you furthermore take into account the tremendous backlash the CMI Report has triggered in the Gulf-War-Illness population, including congressional hearings and serious accusations of the CMI Report being tainted due to an undue influence on the report by the Department of Veterans Affairs, it becomes even more obvious that the IOM cannot afford to backtrack on any of its findings in the CMI Report regarding ME/CFS because the CMI Report rests largely on those.

In a much less significant conflict situation, your office has determined that a conflict of interest exists if a member of an IOM committee under a DHHS/IOM contract has previously stated a position on the issues to be analyzed under the contract (Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health, regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments). In that case, the contract with the IOM was to study the adverse consequences of the Pertussis and Rubella vaccine. The committee member in question had stated his position on this issue in a deposition.

If a position on the contract issues stated in a deposition creates a conflict of interest for an IOM committee member, then surely when the organization itself, the IOM, has publicly stated such a biased position in an official report, the entire organization is unavoidably tainted by a conflict of interest.

The IOM might argue that their prior position regarding ME/CFS does not represent an organizational conflict of interest because the CMI Report was authored by a committee convened specifically for that report. That argument is not tenable because the CMI Report expressly states that the IOM along with the IOM committee assumes entirely all responsibility for the content of the CMI Report (page vii of the CMI Report).[Italics added] It cannot escape responsibility for statements by an IOM committee that the IOM, as an organization, has fully and unconditionally endorsed.

This bias towards the nature of ME/CFS creates an organizational conflict of interest that cannot be remedied and that clearly disqualifies the IOM from being engaged in the study of ME/CFS. The positions on ME/CFS previously stated by the IOM pre-judges any IOM conclusions at the very heart of the IOM Contract.

I specifically request that your office investigate this serious conflict of interest as soon as possible, so that government funds will not be unnecessarily expended on an unavoidably tainted contract.

I would be pleased to respond to any questions you may have.

Sincerely,

Jeannette K. Burmeister

Enclosures:

Open Letter to Secretary Sebelius by 50 ME/CFS Experts of October 25, 2013Open Letter to Secretary Sebelius by ME/CFS Advocates of November 9, 2013

Memorandum dated January 3, 1992 from Richard P. Kusserow, Inspector General, to James O. Mason, Assistant Secretary of Health regarding the “Review of Alleged Conflict-of-Interest in Institute of Medicine Study of the Adverse Consequences of Pertussis and Rubella Vaccines (A-15-90-00054) and attachments

The controversy surrounding the IOM contract continues unabated. On her blog, Occupy CFS, Jennie Spotila has posted a detailed explanation of the process through which IOM reports are generated. Several steps are involved, including a "statement of task," accepting and approving nominations for the IOM panel, drafting a report, reviewing the report, and, finally, submission of the report for independent review. Conflicts of interest among panel members can lead to their disqualification, as will biases that might affect their judgment.

The entire process sounds carefully planned, well delineated, and comfortingly bureaucratic. There are so many clauses, sub-clauses, stipulations and guarantees, that these steps must surely produce something objective, fair, and in our best interests.

What needs to be kept in mind is that it is possible to appear to meet the letter of the law without in any way conforming to its intent. This is known as rhetoric.

Darwin and the sex lives of organizations

The primary goal of any organization is to perpetuate itself. From a Darwinian perspective, this means that it must live long enough to reproduce. It may sound slightly absurd, but organizations survive in much the same way as any other species: by mating with other similar organizations, and spawning committees with agendas corresponding to those of their parent organizations.

The question is: With which organizations has the IOM mated?

The answer to that question may be found in the IOM's report: Gulf War and Health: Treatment for Chronic Multisymptom Illness ( 2013 ) / 5 Review of Treatments for Comorbid and Related Conditions. (You can read the full text HERE.)

In this report, Chronic Fatigue Syndrome is listed as one of the comorbid conditions of CMI ("chronic multisymptom illness" aka Gulf War Illness). In the chapter entitled, "Chronic Fatigue Syndrome" (page 97), treatments for CFS are described as follows:

"Two specific therapies are recommended for people who have CFS: CBT and graded exercise therapy (GET) (CDC, 1994, Mayo Clinic staff, 2011, National Collaborating Centre for Primary Care, 2007). CBT provides a framework for patients to change how they think and feel about their illness and teaches behaviors that provide patients with a greater sense of control over symptoms (CDC, 1994; National Collaborating Centre for Primary Care, 2007). Exercise has been associated with the body’s natural release of endorphins, natural pain relievers. Both exercise and endorphins have been shown to improve a number of the symptoms of CFS and related syndromes (Cleare, 2003; Harber and Sutton, 1984)."Ignoring the actual treatment recommendations for a moment and focusing instead on the citations, we see that the origins of the IOM's treatment recommendations are comprised of the CDC, the UK's National Collaborating Centre for Primary Care (originator of the NICE guidelines), and the Mayo Clinic staff - which is simply an iteration of the CDC. (The two research citations serve as filler: the Cleare study - from the Institute of Psychiatry in London - did not investigate exercise as a treatment, and the Harber and Sutton study had nothing to do with either ME or CFS.)

In the remaining paragraphs of this section, only the CDC and National Collaborating Centre for Primary Care are cited.

Given the paucity of references to actual ME and CFS studies, and no inclusion at all of organizations that specialize in researching ME or CFS (e.g. Simmaron), we can only conclude that the IOM prefers to mate with its own kind, which, in this case, are not medical experts, or even medical researchers, but government agencies.

What can we expect?

By now, we have a good idea of the sort of report the IOM will produce, because we can read what was recommended for Gulf War veterans. But there is more to this story.

In March 2013, Mr. Anthony Hardie, a Gulf War veteran, testified before the Veterans’ Affairs Subcommittee on Oversight and Investigations alleging subversion of the intent of the IOM report. Mr. Hardie testified that the report was manipulated to form a "treatments" panel that "diverged radically from both the Congressional authorizing language and established science." Mr. Hardie went on to say that "the panel was charged by VA to conduct a literature review rather than to consult with knowledgeable medical practitioners experienced in treating ill Gulf war veterans. And nearly all of the first presenters focused on "stress-as-cause", psychological, and psychosomatic issues – all debunked years ago."

The literature review, as indicated by the references in the CFS section, was highly selective, obviously cherry-picked to conform to the panel's agenda. In this way, the panel subverted the intent of the law in order to create something that appeared to satisfy Congressional requirements, while simply fulfilling an agenda of its own.

Going over their heads

In spite of having a government that is "by the people, of the people, and for the people" it is clear that the institutional commitments of government agencies are to themselves, rather than to citizens - which is why we have citizens' groups. This is the way it should be. Institutions are given a great deal of power over individuals, and the only way to limit that power is through the watchdog activities of citizens, and through our own insistence on following not just the letter, but the intent of the law.

Mr. Hardie made it clear in his testimony that the manipulation of the IOM report to re-interpret GWI as a psychological ailment should be considered a breach of the law. Among others, he recommended the following actions:

A provision making it a crime punishable by federal imprisonment for a government employee or contractor to attempt to manipulate an IOM report ordered by a government agency, or for an IOM employee or member to conspire with a government employee or contractor for the purpose of manipulating a report.

A provision directing VA to immediately terminate the IOM case definition contract [italics added]and contract instead with the DoD Congressionally Directed Medical Research Programs (CDMRP) Gulf War Illness program to develop a case definition that is linked to Gulf War service and excludes mental conditions, and that follows customary case definition practices (including assembling a committee of experts in the illness, who can consult original data sources).

While those of us with ME/CFS are not the responsibility of any institution - unlike veterans, who are supposedly represented by the VA - there is no reason why people with ME/CFS can't make the same demand of HHS. It is a branch of government that we not only pay for, but which is entrusted with our welfare.

The squeaky wheel gets greased

In a recent conversation with a representative from one of our federal departments, I asked the question, "What can I do?" The answer was, "Complain, complain, complain."

The most efficient way to complain is through a group. Unfortunately, we don't have a national organization that represents the interests of ME/CFS patients. (NAAME is a fledgling group that may one day fulfill that role.) We do, however, have local and regional groups that are supposed to represent the interests of ME/CFS patients.

What we can do:

Pressure ME/CFS groups to take an official stand against the IOM contract. Some of these groups are non-profits, others are simply ad hoc organizations, but all of them have more clout than a single individual. And all of them respond to input from members and from patients in their regions. These groups can send a letter to HHS - and to their representatives - in the organization's name and post it on their websites. (Go HERE for a list of groups.)

Sign the three petitions (here, here and here), and send letters to your representatives. (See instructions HERE.) This is easy and quick - and numbers count.

Write a letter to the editor of your local newspaper. The "letters to the editor" section of the newspaper is still the one people read first. Now, of course, you can post letters online. Whenever you see an article about CFS, (there was one recently on Jennifer Brea's film, Canary in a Coal Mine), write about the IOM contract. Whenever you see an article about health care, or health conditions, or anything related, write about the IOM contract.

Complain, complain, complain to the HHS at Kathleen.Sebelius@hhs.gov.

Last, but not least - TWEET!!! Go HERE to participate in the IOM contract tweet campaign.

In the end, all of our complaints will amount to "public outcry." History has proven that with enough public outcry, even the mightiest institutions will bend.

Health and Human Services’ (HHS) decision to entrust the new definition of ME and CFS to the Institute of Medicine (IOM) has generated a firestorm of controversy, dividing members of the ME/CFS community into three camps: pro, con and confused.

With the CFIDS Association of America’s endorsement of the IOM contract, (1) and Dr. Bateman's subsequent shift of position, (2) the two opposing camps have become increasingly contentious, while the third is suffering from acronym overload.

Most people with ME/CFS prefer to avoid conflict at all costs, so this division generates, if not an outright headache, something akin to an emotional migraine. Even if we want to be kept informed, after a while the discussion blurs into a dense fog of shifting accusations and counter-accusations that we simply cannot absorb.

There is a strong temptation to simply ignore it all, and let the chips fall where they may. After all, this is not the first time the CFS/ME community has been divided, and it won’t be the last. In any case, a new definition won’t change the realities of the illness ... Or will it?

Why is the case definition important?

As far as research, diagnosis, and treatment are concerned, nothing is more important than a case definition. For researchers, a case definition is used to establish a patient cohort. If a definition is too open-ended, researchers may end up including people who do not have the illness they are studying, thus invalidating their results. For physicians, a case definition is used to diagnose patients, which will then, hopefully, lead to appropriate treatment.

The current case definition of CFS in the United States, the “Fukuda” definition (named for its first author) fails on all of these counts. It was developed in 1994 by a group that included a roster of physicians with highly disparate orientations – from Steven Strauss, Michael Sharpe and Simon Wessely, who believed that the illness they were defining was a psychiatric disorder, to Anthony Komaroff and Dan Peterson, who knew it wasn’t. The diverse backgrounds of these authors, some of whom had no direct clinical experience with the illness, made for a definition that was, like the ungainly camel, “designed by a committee.” By the time this group was ready to publish the new definition, consensus still had not been reached. (3)

In the end, a broad definition of CFS was adopted, leading, as many suspected it would, to problems establishing patient cohorts for research, inaccurate diagnoses, and a widespread belief among the general public and most physicians that the illness could be equated with “tiredness.” Nineteen years later, after pressure from patients and the professional community, as well as the CFSAC, the “Fukuda” definition was finally recognized as inadequate by the federal government.

The development of an accurate case definition

The primary sticking point in the Fukuda case definition is that Post-Exertion Malaise (PEM) is optional, which means patients with major depression - as well as patients with early MS, some forms of leukemia, genetic disorders, incipient heart disease, Hashimoto’s disease, diabetes, and numerous other ailments that a CBC might have missed – may be included. This is a disaster not just for researchers who don’t have a reliable means of establishing a patient cohort (and for patients who end up waiting years for a diagnosis), but for thousands of patients who don’t have CFS. These patients often have illnesses such as early MS (which presents as fatigue), Hashimoto’s disease (which causes profound exhaustion, and does not alter standard lab results until it is advanced), or any one of the myriad other illnesses that begin with fatigue. Because a diagnosis of CFS often produces an admonition to exercise, and perhaps a prescription for antidepressants, for these patients, “CFS” can be fatal.

The numerous shortcomings of the Fukuda definition motivated a group of experienced clinicians and researchers to devise their own. This was the Canadian Consensus Criteria (CCC), which was published in the Journal of Chronic Fatigue Syndrome in 2003. (4) In sharp contrast to the Fukuda definition, the CCC requires PEM, as well as neurological, neurocognitive, neuroendocrine, dysautonomic, circulatory, and immune symptoms.Over the past ten years, researchers who are serious about establishing reliable cohorts have employed the CCC. Clinical ME/CFS specialists also prefer the CCC, finding it to be more accurate for making a diagnosis. (According to a 2011 study led by Leonard Jason, the CDC “Fukuda” criteria only identified 79% of patients with CFS/ME, while the CCC identified 87%). (5) But while the CCC has been used for a decade by serious researchers and clinicians, it is not entirely surprising that the federal government has been slow on the uptake. Federal funding for CFS has been minimal at best, creating minimal interest in the illness on all levels.

The IOM contract – from suspicion to dread

True to form, the federal government decided that rather than adopt a case definition that had been created and successfully used by experts, they would rather reinvent the wheel. On August 28th, HHS announced that it intended to hire the Institute of Medicine (IOM) to formulate a new case definition for CFS. This raised the suspicions of ME/CFS advocates both for the timing of the announcement (right before Labor Day), and for the speed with which HHS intended to assign the contract. (After 19 years, why the sudden rush?)

Suspicions were further confirmed when it was discovered that the IOM not only had little experience in defining illnesses, but that their previous definition of Gulf War Illness as “chronic multi-symptom illness” had met with universal criticism from GWI patients, clinicians and researchers. “Chronic multi-symptom illness,” as GWI advocates correctly pointed out, could describe just about any long-term illness. In effect, Gulf War Illness had been “undefined.” What was more, the IOM’s recommended treatments for “CMI” consisted of antidepressants and cognitive behavioral therapy.(6) There was every indication that CFS was going to suffer the same fate.

Patients and advocates immediately began bombarding HHS Secretary Kathleen Sebelius with letters. It appeared as if the IOM contract had been halted when HHS issued a statement that it was no longer going to pursue its solicitation of the IOM, a statement which was almost immediately revoked when it turned around and hired IOM on September 23rd.The response was instantaneous. The same day that HHS announced it was going forward with the contract, a letter signed by 35 top ME/CFS physicians both in the US and abroad was sent to Secretary Sebelius requesting that HHS drop the IOM contract, and asking for the immediate adoption of the CCC. Within the month, 16 more experts had signed the letter, bringing the total to 50. (7)

One would think that with such an unequivocal statement from the leading researchers and clinicians in the field that HHS would take notice. More to the point, one would think that the ME/CFS community itself would rally around such an unprecedented move. And, to a large extent it did, with letters of support coming from the National Alliance for ME (NAME), Dr. Lilu Chu, and Dr. Eleanor Stein, and no fewer than three petitions. There was, however, one notable exception to this outpouring of approval.

Fifth columnists

The CFIDS Association of America, the largest ME/CFS non-profit in the country, against all apparent logic, decided to endorse the IOM contract. There appeared to be no solid reason for the endorsement other than the hope that the IOM contract would “open federal doors.” In marked contrast to the position taken by nearly all the experts in the field, the CAA came to the conclusion that the IOM contract would be an “opportunity” rather than a debacle.

To bolster what was undoubtedly going to be an unpopular position, the CAA sent an email to all the experts who had signed the letter, asking them (indirectly) to reverse their position. One signatory, Dr. Lucinda Bateman, did so, citing the reasons that had been put forth by the CAA. (Dr. Bateman serves on the CAA’s Research Advisory Council.) One ME/CFS advocacy organization, PANDORA, also published an endorsement of the IOM contract, using much the same language.

Drawing fire

As might be predicted, the reaction to the CAA’s ill-disguised attempt to persuade the experts to rescind their signatures came swiftly. Dr. Mikovits responded with a tart rejoinder:“I know that the CAA is not and has never in my experience responded to concerns expressed by the patients, nor do they now or have they ever served in the best interests of the patients, as is the only duty of an advocacy organization. This IOM contract is simply a waste of precious resources. I stand by my signature on the letter and my work which is now always has been and will always be in the best interests of the patients.” (8)

Advocates claimed that a conflict of interests might be involved. Suzanne Vernon, scientific director of the CAA, is on the IOM panel that defined Gulf War Illness as “chronic multi-symptom illness.” Critics pointed out that the CAA itself had benefited from its long association with government agencies, and might continue to do so because of its role in the IOM contract. (The CAA earned over $8 million in government grants during 2000-2007. As of 2008, government grants ceased to be a line item on non-profit IRS forms.)

This wave of criticism prompted a response from Suzanne Vernon (originally posted without a signature), in which she attempted to “clear the air.” (9) Her effort at setting the record straight was greeted with skepticism, if not outright derision.

PANDORA’s endorsement of the IOM contract met with much the same reaction. PANDORA's statement that it would “do all [it] can to avoid an IOM definition disaster…" was characterized as delusional. (10) And PANDORA's assurance that the IOM would be open to ME/CFS experts who "have the experience and knowledge to define the disease" and that “any effort to update the definition should start with the 2003 CCC” was judged to be either "naïve or co-opted." *Shortly after PANDORA issued its statement, a group of 60 patient forum leaders, not-for-profit organization managers, scholars, authors, filmmakers, bloggers and other advocates signed a letter addressed to Secretary Sebelius, voicing their support for experts' letter.

You can’t get there from here

Like the punchline of an old joke, the real question is whether we can get there from here. Can the IOM contract really open doors? Will HHS adopt a precise definition of ME/CFS that requires the hallmark symptom of PEM? Will the experts on the IOM panel be real experts, rather than people who happen to have connections with the IOM? Can the ME/CFS community exert its influence to make sure the IOM definition is conducive to better research, diagnosis and treatment?

These are big questions, and the answer to all of them is "no."

History has shown us that we cannot change HHS "from within." Government institutions have a vested interest in maintaining the staus quo for the simple reason that advancement within those institutions is predicated on not rocking the boat. Independent thinking, especially when it contradicts the received wisdom of people higher up in the chain of command, is actively discouraged in government service. In the case of ME/CFS, the status quo is comprised of lack of funding for ME/CFS research, a dismissive attitude towards the illness (couched in kinder, gentler "discussions"), the obstruction of the approval of drugs which might actually be of benefit to the sickest members of our community (Ampligen), and the perpetuation of the myth that the illness is fundamentally psychogenic and can be mitigated through therapy and exercise.

There is a lot at stake here, much more than meets the eye. So, regardless of the “friendly fire,” online arguments, and heated exchanges coming out of this battle, it is absolutely essential that members of the ME/CFS community stay clear and rational.A redefinition of CFS as “chronic multi-symptom illness,” or any other meaningless concatenation, will not improve upon the current definition, it will not lead to effective treatment, it will not increase funding for research, and it will not lead to acceptance by the medical community. Instead, it will usher in the widespread dismissal of ME/CFS as an organic illness, and cause a halt in meaningful research. As the experts have rightly pointed out, “this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable. ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste.”

In a nutshell

Hillary Johnson and other knowledgeable advocates have observed that over the past 30 years the government agencies entrusted with our welfare have repeatedly done everything in their power to relegate CFS to the dustbin of psycho-social illness. There is no indication that HHS has made any change in this long-standing policy. Johnson's advice on this matter is: No cooperation, only resistance.

Fifty of the world’s leading experts in the field of ME/CFS treatment and research have categorically rejected the IOM contract, and have endorsed the CCC as the sole definition for ME/CFS.

There is at present a world-wide effort to officially, and permanently, categorize ME and CFS as psychological illnesses. The IOM contract is part of that effort.(11)

The ME/CFS community is not divided on the issue of the IOM contract. Thousands of people have signed the petition to revoke the IOM contract, as well as the petition to adopt the CCC. Only two organizations have backed the IOM contract, the CAA and PANDORA. The majority of our ME/CFS organizations have not.

Author

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About me:I'm a 25-year veteran of CFIDS. I know what it is like to be bedbound for long stretches of time. I also know what it is like to recover, and to relapse. But this blog is not about my personal experience. It is intended to be a resource - a collection of anything that might be helpful to the CFIDS community: book reviews, advice, CFIDS news, research, advocacy, opinion, who's who in our community, fundraising... and occasionally a bit of humor.

Disclaimer: I am not a doctor, which means nothing I write, no matter how sensible it may be, should be interpreted as medical advice.